Otc - Active Ingredient
Active ingredient PurposeBenzocaine, 20%........................................Oral Anesthetic
Cvs Oral Anesthetic
FDA Label NDC 59779-186
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Oral Anesthetic (NDC 59779-186). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses- temporary relieves pain associated with the following mouth and gum irritations: - toothache - canker sores - sore gums - braces - dentures- minor dental procedures
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If more than is used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Uses- temporary relieves pain associated with the following mouth and gum irritations:
- toothache - canker sores - sore gums - braces - dentures- minor dental procedures
Warnings
Warnings Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.When using this product- avoid contact with eyes- do not exceed recommended dosage- do not use for more than 7 days unless directed by a doctor/dentistStop use and ask a dentist or a doctor if- sore mouth symptoms do not improve in 7 days- swelling, rash or fever develops- irritation, pain or redness persists or worsensKeep out of reach of children.If more then used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions- Adults and children 2 years of age and older: apply to the affected area- wipe liquid on with cotton, or cotton swab, or fingertip- apply up to 4 times daily or as recommended by a doctor/dentist- Children under 12 years of age: adult supervision should be given in the use of this product- children under 2 years of age: consult a dentist or doctor
Inactive Ingredient
Inactive Ingredientsbenzyl alcohol, D and C Yellow no 10, FD and C Blue no 1, FD and C Red no 40, flavor, methylparaben, polyethylene glycol, propylene glycol, saccharin
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